Eisai criticises NICE and CDF for rare cancer ‘black hole’ in England
pharmafile | July 8, 2016 | News story | Medical Communications, Research and Development | CDF, Eisai, NICE, black hole
Japanese pharmaceutical company Eisai (TYO: 4523) has issued a statement expressing its dismay that advanced thyroid cancer patients in England may have to wait up to three years to access Lenvima (lenvatinib) due to what it calls a ‘black hole’ in the inequitable re-launched Cancer Drugs Fund (CDF) process.
Now under the jurisdiction of the National Institute of Health and Care Excellence (NICE), Lenvima is not included in the Cancer Drugs Fund and NICE guidance will not be available on the drug until at least 2018, according to Eisai.
Lenvima, which was approved by the EU in March 2015, is indicated for the treatment of adults with progressive locally advanced or metastatic, differentiated thyroid carcinoma. Late-stage data for the drug suggestsan 18.3 months progression free survival rate versus 3.6 months for placebo. Eisai has criticised NHS England in the past for the delays and uncertainty in allowing Lenvima to be accessed by patients on the NHS.
The company now calls for a transitional arrangement to allow access for Lenvima, which it says was “caught in limbo” because it was not appraised before the CDF closed. It did not qualify for NICE appraisal at the time, because of its low budget impact for the NHS. Eisai is now considering legal action, among other options, to secure access to this and other rare cancer drugs.
Gary Hendler, chairman and CEO of Eisai EMEA, says: “It is sad that patients living in England cannot access lenvatinib for advanced thyroid cancer which was developed and manufactured in this country. We believe there is an immediate solution, a transitional arrangement, to allow patients access to a treatment which has been disproportionately delayed by the changes in the CDF process.
“Eisai may be forced to consider its level of investment in the UK because it is unacceptable that drugs which are manufactured in England cannot be provided to people in England, without delays of many years.”
Georgina Gerrard, consultant clinical oncologist at The Leeds Teaching Hospitals, comments: “As a clinician I am appalled by this latest delay in access to the treatment. I treat people with advanced thyroid cancer, refractory to radio-iodine treatment who are eligible for lenvatinib, but remain unable to receive the treatment due to red tape. I call on NHS England to allow clinicians like me to prescribe this treatment to my patients today.”
Update
A spokesperson for NICE, reacting to Eisai’s criticisms, told Pharmafile.com: “Lenvatinib was licensed prior to the changes to the CDF. It was originally considered for a technology appraisal in early 2012 but was not considered appropriate to be formally referred to NICE at that time. Due to the changes to the CDF, NICE have now committed to an appraisal of lenvatinib, however the topic must be formally referred to NICE by the Department of Health before the appraisal can begin. We are working with the DH to ensure lenvatinib is referred as soon as possible.
“From now on all cancer drugs will begin the NICE appraisal process before they are licensed with draft recommendations ready at the point of positive opinion from the CHMP with final guidance published within 90 days of receipt of the Marketing Authorisation. This is faster than any other European nation and will benefit NHS patients and pharmaceutical companies alike.”
Sean Murray
Related Content
Combination treatments: Takeda’s Implementation Framework and the broader landscape
Pharmafile talks to Emma Roffe, Oncology Country Head (UK & Ireland) about the combination treatment …
NICE recommends Pfizer’s new once-weekly treatment for haemophilia B on NHS
Walton Oaks, 21st May 2025 – Pfizer Ltd announced today that the National Institute for Health and Care …
Dual immunotherapy for bowel cancer now available under NHS
Dual immunotherapy, a combination of Opdivo (nivolumab) and Yervoy (ipilimumab), has been granted extension in …
